Working... Menu

Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00043043
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Celecoxib may be effective in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: celecoxib Phase 2

Detailed Description:



  • Compare the effects of celecoxib vs placebo on the number of rectal aberrant crypt foci in patients with premalignant rectal polyps or prior sporadic colorectal neoplasia.


  • Compare the effects of these drugs on proliferation index, apoptotic index, and gene expression patterns in ascending and descending colon tissue from these patients before and after treatment.
  • Assess gene expression patterns in normal mucosa from the ascending vs descending colon in patients referred for screening, surveillance, or diagnostic colonoscopy.

OUTLINE: This is a randomized, double-blind, placebo-controlled, chemoprevention study. Patients are stratified according to age (18 to 49 vs 50 and over) and number of rectal aberrant crypt foci (5-9 vs 10 or more).

All patients undergo a baseline biomarker assessment and full colonoscopy to resect all neoplasms, quantitate rectal aberrant crypt foci, and biopsy rectal mucosa.

Depending on the results of the biomarker assessments, patients are randomized to 1 of 2 treatment arms. Patients with no adenomas of 5 mm or greater receive no further treatment.

  • Arm I: Patients receive oral celecoxib twice daily.
  • Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity.

All patients undergo an endoscopic exam of the colorectum at completion of study.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for the baseline biomarker assessment and a total of 40 patients (20 per arm) will be accrued for the chemoprevention study within 1 year.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Rectal Abberant Crypt Foci And Other Intermediate Biomarkers For Sporadic Colorectal Neoplasia: Cross-Sectional Prevelance And Modulation By Celecoxib
Study Start Date : May 2003
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Celecoxib

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Age 18 to 49 with one of the following colorectal abnormalities:

    • At least one adenoma that is at least 1 cm
    • At least 3 adenomas of any size with at least 5 rectal aberrant crypt foci (ACFs)
  • Age 50 and over with one of the following colorectal abnormalities:

    • At least one adenoma that is at least 5 mm and at least 5 rectal ACFs
    • History of polyps (at least 1 adenoma) within the past 5 years
  • No history of germline cancer syndrome
  • No stage III or IV colorectal cancer (Dukes' C or D) diagnosed within the past 6 months
  • No current colorectal cancer
  • No inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)



  • See Disease Characteristics
  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Hemoglobin greater than 11.5 g/dL
  • WBC greater than 3,000/mm^3
  • Platelet count greater than 125,000/mm^3
  • No significant bleeding disorder


  • AST and ALT no greater than 1.5 times upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN
  • Alkaline phosphatase no greater than 1.5 times ULN
  • No chronic or acute hepatic disorder


  • Creatinine no greater than 1.5 times ULN
  • No chronic or acute renal disorder


  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure


  • No asthma
  • No severe chronic obstructive pulmonary disease


  • No active gastrointestinal ulcers
  • No history of peptic ulcer disease


  • No prior hypersensitivity reaction to NSAIDs, aspirin, or sulfa drugs
  • No medical contraindication to NSAID use
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile female patients must use effective contraception
  • No known allergic reaction to indigo carmine
  • No other clinically significant medical condition or abnormal laboratory value that would preclude study participation


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Anticipated use of corticosteroids less than 2 weeks over 6 months
  • Anticipated use of mometasone less than 4 weeks over 6 months

    • No other concurrent inhaled steroids for 30 days before or during study participation


  • No prior pelvic radiotherapy


  • Not specified


  • More than 30 days since prior investigational drugs
  • No prior participation in this study
  • No regular nonsteroidal anti-inflammatory drug (NSAID) or aspirin use (average of 3 or more doses per week for at least 3 months) except low-dose aspirin for cardiovascular disease prophylaxis
  • No other concurrent investigational drugs
  • No concurrent fluconazole or lithium

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00043043

Layout table for location information
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889-5600
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Ernest Hawk National Cancer Institute (NCI)

Layout table for additonal information Identifier: NCT00043043     History of Changes
Obsolete Identifiers: NCT00056615
Other Study ID Numbers: CDR0000069498
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: November 2004

Keywords provided by National Cancer Institute (NCI):
colorectal cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action